CClinicalTrials.gg
CompletedNCT02792959IMOVAUpdated Apr 21, 2021Results posted

Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging

An interventional study of Functional Imaging previous the second course and Functional Imaging previous the surgery in Ovarian Cancer, sponsored by Institut Bergonié. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-21.

Sponsored by Institut Bergonié · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.

Read the detailed description

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent. It is a single center evaluation of the study treatment.

02

Conditions studied

03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 11 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Epithelial ovarian carcinoma, fallopian tube, or primary peritoneal carcinoma FIGO IIIC-IV histologically confirmed by biopsy and documented stage and untreated
  • Pre-treatment abdominopelvic PET-CT and MRI within 4 weeks before neoadjuvant chemotherapy.
  • During laparoscopy performed by an experienced surgeon in the treatment of ovarian cancer, patient considered ineligible for tumor cell kill at the outset.
  • A life expectancy of greater than three months
  • An eligible patient for Paclitaxel and Carboplatine based chemotherapy.
  • Membership of a social security scheme
  • Patient information and signed, dated written informed consent

Exclusion criteria

Exclusion Criteria:

  • Pre-treated using chemotherapy, radiology, or surgery for an ovarian cancer.
  • Contraindication to MRI with the injection of contrast product, i.e, the first three months pregnancy, claustrophobia, major allergic antecedents, pacemaker, some surgery clips, some heart valves, cava filter, implanter pumps, cochlear implants, metallic extraneous malter.
  • Uncontrolled diabetes
  • Pregnancy and nursing
  • Other uncontrolled medical conditions as thyroid pathology, neuropsychiatric disease, infection, coronary insufficiency or grade 3 - 4 heart disease established by association "New York Heart"
  • Patient deprived of liberty and legally protect adult, or not in position to give consent.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Functional imaging

    A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)

    Device: Functional Imaging previous the second course · Device: Functional Imaging previous the surgery

Interventions

  • DeviceFunctional Imaging previous the second course

    Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1

  • DeviceFunctional Imaging previous the surgery

    Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval

06

What researchers measure

Primary outcomes

  1. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: Pre-therapeutic

  2. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: Pre-therapeutic

  3. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: Pre-therapeutic

  4. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: Pre-therapeutic

  5. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: Pretherapeutic

  6. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: Pretherapeutic

  7. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist.

    Time frame: After one cycle of chemotherapy, 3 weeks

  8. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) . The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After one cycle of chemotherapy, 3 weeks

  9. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After one cycle of chemoterapy, 3 weeks

  10. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After one cycle of chemotherapy, 3 weeks

  11. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After one cycle of chemotherapy, 3 weeks

  12. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After one cycle of chemotherapy, 3 weeks

  13. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After four cycles of chemotherapy, 12 weeks

  14. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After four cycles of chemotherapy, 12 weeks

  15. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After four cycles of chemoterapy, 12 weeks

  16. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After four cycles of chemotherapy, 12 weeks

  17. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After four cycles of chemotherapy, 12 weeks

  18. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

    Time frame: After four cycles of chemotherapy, 12 weeks

  19. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: Pre-therapeutic

  20. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: Pre-therapeutic

  21. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: Pre-therapeutic

  22. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: Pre-therapeutic

  23. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: Pretherapeutic

  24. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) . The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: Pretherapeutic

  25. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After one cycle of chemoterapy, 3 weeks

  26. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After once cycle of chemoterapy, 3 weeks

  27. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After one cycle of chemoterapy, 3 weeks

  28. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After once cycle of chemotherapy, 3 weeks

  29. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After one cycle of chemotherapy, 3 weeks

  30. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After one cycle of chemotherapy, 3 weeks

  31. Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After four cycles of chemoterapy, 12 weeks

  32. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After four cycles of chemoterapy, 12 weeks

  33. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After four cycle of chemoterapy, 12 weeks

  34. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After four cycles of chemotherapy, 12 weeks

  35. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After four cycles of chemotherapy, 12 weeks

  36. Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

    Time frame: After four cycles of chemotherapy, 12 weeks

Secondary outcomes

  1. Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

    Time frame: After one cycle of chemotherapy, 3 weeks

  2. Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

    Time frame: After four cycles of chemotherapy, 12 weeks

  3. Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

    Time frame: After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)

  4. Complete Surgery Resection

    Time frame: Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery

  5. Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After one cycle of chemotherapy, 3 weeks

  6. Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. RRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After four cycles of chemotherapy, 12 weeks

  7. Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After four cycles of chemotherapy, 12 weeks

  8. Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After one cycle of chemotherapy, 3 weeks

  9. Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After one cycle of chemotherapy, 3 weeks

  10. Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After four cycles of chemotherapy, 12 weeks

  11. Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After one cycle of chemotherapy, 3 weeks

  12. Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After four cycles of chemotherapy, 12 weeks

  13. Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After one cycle of chemotherapy, 3 weeks

  14. Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After four cycles of chemotherapy, 12 weeks

  15. Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After one cycle of chemotherapy, 3 weeks

  16. Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

    Time frame: After four cycles of chemotherapy, 12 weeks

  17. Peritoneal Extent Assessed by Fagotti Score Using MRI Data

    The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscale values corresponds to Fagotti score.

    Time frame: Pre-therapeutic

  18. Peritoneal Extent Assessed by Fagotti Score Using MRI Data

    TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscales corresponds to Fagotti score.

    Time frame: Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery

  19. Overall Survival

    Time frame: 10 months

  20. Progression-free Survival as Per RECIST v1.1

    Time frame: 9, 13, 14 months

07

Results

Posted Apr 21, 2021

Participant flow

Participant flow — Overall Study
MilestoneFunctional Imaging
Started11
Completed10
Not completed1
Withdrew: Protocol violation1

Outcome measures

PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
Pre-therapeutic
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.992 (0.969 to 0.998)
Sus-mesocolic0.997 (0.987 to 0.999)
Sub-mesocolic0.983 (0.937 to 0.996)
Pelvis0.997 (0.988 to 0.999)
Viscera0.951 (0.826 to 0.987)
ADP0.960 (0.853 to 0.990)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
Pre-therapeutic
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.996 (0.984 to 0.999)
Sus-mesocolic0.999 (0.993 to 1.000)
Sub-mesocolic0.992 (0.968 to 0.998)
Pelvis0.998 (0.994 to 1.000)
Viscera0.975 (0.905 to 0.994)
ADP0.980 (0.921 to 0.995)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
Pre-therapeutic
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.482 (-0.079 to 0.833)
Sus-mesocolic0.450 (-0.165 to 0.824)
Sub-mesocolic0.137 (-0.606 to 0.698)
Pelvis0.747 (0.298 to 0.929)
Viscera0.023 (-0.586 to 0.616)
ADP0.881 (0.614 to 0.969)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
Pre-therapeutic
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.650 (-0.173 to 0.909)
Sus-mesocolic0.621 (-0.396 to 0.904)
Sub-mesocolic0.241 (-3.081 to 0.822)
Pelvis0.855 (0.460 to 0.963)
Viscera0.044 (-2.827 to 0.762)
ADP0.937 (0.761 to 0.984)
PrimaryInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
Pretherapeutic
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.813 (0.292 to 0.960)
Sus-mesocolic0.922 (0.723 to 0.980)
Sub-mesocolic0.794 (0.393 to 0.944)
Pelvis0.178 (-0.567 to 0.718)
Viscera0.983 (0.925 to 0.996)
ADP0.974 (0.896 to 0.994)
PrimaryInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
Pretherapeutic
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.897 (0.452 to 0.980)
Sus-mesocolic0.960 (0.834 to 0.990)
Sub-mesocolic0.885 (0.564 to 0.971)
Pelvis0.302 (-2.620 to 0.836)
Viscera0.991 (0.961 to 0.998)
ADP0.987 (0.945 to 0.997)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist.

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.992 (0.969 to 0.998)
Sus-mesocolic0.884 (0.607 to 0.970)
Sub-mesocolic0.983 (0.934 to 0.996)
Pelvis0.998 (0.993 to 1.000)
Viscera0.317 (-0.332 to 0.770)
ADP0.977 (0.913 to 0.994)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) . The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.996 (0.684 to 0.999)
Sus-mesocolic0.938 (0.755 to 0.985)
Sub-mesocolic0.991 (0.966 to 0.998)
Pelvis0.999 (0.996 to 1.000)
Viscera0.482 (-0.993 to 0.870)
ADP0.989 (0.954 to 0.997)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After one cycle of chemoterapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.504 (-0.537 to 0.842)
Sus-mesocolic0.882 (0.618 to 0.969)
Sub-mesocolic0.210 (-0.439 to 0.719)
Pelvis0.699 (0.200 to 0.915)
Viscera0.486 (-0.137 to 0.840)
ADP0.994 (0.976 to 0.998)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.670 (-0.114 to 0.914)
Sus-mesocolic0.937 (0.764 to 0.984)
Sub-mesocolic0.347 (-1.564 to 0.837)
Pelvis0.823 (0.333 to 0.955)
Viscera0.654 (-0.318 to 0.913)
ADP0.997 (0.988 to 0.999)
PrimaryInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.807 (0.321 to 0.958)
Sus-mesocolic0.340 (-0.154 to 0.757)
Sub-mesocolic-0.080 (-0.703 to 0.564)
Pelvis0.566 (-0.055 to 0.871)
Viscera0.747 (0.240 to 0.931)
ADP0.863 (0.537 to 0.967)
PrimaryInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.893 (0.486 to 0.978)
Sus-mesocolic0.507 (-0.365 to 0.862)
Sub-mesocolic0.885 (0.564 to 0.971)
Pelvis0.723 (-0.116 to 0.931)
Viscera0.855 (0.387 to 0.964)
ADP0.926 (0.698 to 0.983)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Sus-mesocolic0.923 (0.738 to 0.980)
Sub-mesocolic0.953 (0.824 to 0.988)
Pelvis0.962 (0.856 to 0.990)
ADP0.942 (0.796 to 0.985)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Sus-mesocolic0.960 (0.849 to 0.990)
Sub-mesocolic0.976 (0.904 to 0.994)
Pelvis0.981 (0.922 to 0.995)
ADP0.970 (0.887 to 0.992)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After four cycles of chemoterapy, 12 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Sus-mesocolic0.957 (0.838 to 0.989)
Sub-mesocolic0.248 (-0.368 to 0.733)
Pelvis0.998 (0.992 to 0.999)
ADP0.943 (0.794 to 0.986)
PrimaryInter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Geometric mean · proportion of agreement
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Sus-mesocolic0.978 (0.912 to 0.995)
Sub-mesocolic0.398 (-1.163 to 0.846)
Pelvis0.999 (0.996 to 1.000)
ADP0.971 (0.885 to 0.993)
PrimaryInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Number · proportion of agreement
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.961 (0.804 to 0.992)
Sus-mesocolic0.730 (0.265 to 0.924)
Sub-mesocolic0.862 (0.543 to 0.964)
Pelvis0.543 (0.059 to 0.861)
Viscera0.834 (0.491 to 0.955)
ADP1.000 (1.000 to 1.000)
PrimaryInter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Number · proportion of agreement
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.980 (0.891 to 0.996)
Sus-mesocolic0.844 (0.419 to 0.960)
Sub-mesocolic0.926 (0.704 to 0.982)
Pelvis0.703 (0.126 to 0.925)
Viscera0.910 (0.659 to 0.977)
ADP1.000 (1.000 to 1.000)
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
Pre-therapeutic
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic1.000 (1.000 to 1.000)
Sus-mesocolic0.998 (0.991 to 0.999)
Sub-mesocolic1.000 (0.998 to 1.000)
Pelvis0.997 (0.987 to 0.999)
Viscera1.000
ADP0.985 (0.942 to 0.996)
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
Pre-therapeutic
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic1.000 (1.000 to 1.000)
Sus-mesocolic0.999 (0.995 to 1.000)
Sub-mesocolic1.000 (0.999 to 1.000)
Pelvis0.998 (0.994 to 1.000)
Viscera1.000
ADP0.992 (0.970 to 0.998)
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
Pre-therapeutic
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.987 (0.951 to 0.997)
Sus-mesocolic0.622 (0.041 to 0.890)
Sub-mesocolic0.493 (-0.212 to 0.858)
Pelvis0.847 (0.513 to 0.959)
Viscera0.042 (-0.572 to 0.623)
ADP0.934 (0.770 to 0.983)
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
Pre-therapeutic
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.993 (0.975 to 0.998)
Sus-mesocolic0.767 (0.079 to 0.942)
Sub-mesocolic0.660 (-0.538 to 0.924)
Pelvis0.917 (0.678 to 0.979)
Viscera0.080 (-2.668 to 0.771)
ADP0.966 (0.870 to 0.991)
PrimaryIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
Pretherapeutic
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.747 (0.136 to 0.944)
Sus-mesocolic0.894 (0.634 to 0.972)
Sub-mesocolic0.452 (-0.122 to 0.821)
Pelvis0.217 (-0.481 to 0.730)
Viscera0.639 (0.093 to 0.895)
ADP0.961 (0.839 to 0.991)
PrimaryIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) . The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
Pretherapeutic
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.855 (0.240 to 0.971)
Sus-mesocolic0.944 (0.776 to 0.986)
Sub-mesocolic0.623 (-0.279 to 0.902)
Pelvis0.356 (-1.855 to 0.844)
Viscera0.780 (0.170 to 0.944)
ADP0.980 (0.912 to 0.995)
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After one cycle of chemoterapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.893 (0.636 to 0.972)
Sus-mesocolic0.998 (0.994 to 1.000)
Sub-mesocolic0.993 (0.970 to 0.998)
Pelvis0.997 (0.987 to 0.999)
Viscera0.317 (-0.332 to 0.770)
ADP1.000 (1.000 to 1.000)
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After once cycle of chemoterapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.943 (0.777 to 0.986)
Sus-mesocolic0.999 (0.997 to 1.000)
Sub-mesocolic0.996 (0.985 to 0.999)
Pelvis0.999 (0.994 to 1.000)
Viscera0.482 (-0.993 to 0.870)
ADP0.482 (-0.993 to 0.870)
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After one cycle of chemoterapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.789 (0.384 to 0.942)
Sus-mesocolic0.898 (0.661 to 0.973)
Sub-mesocolic0.967 (0.866 to 0.992)
Pelvis0.329 (-0.311 to 0.774)
Viscera0.193 (-0.450 to 0.710)
ADP0.997 (0.988 to 0.999)
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After once cycle of chemotherapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.882 (0.555 to 0.970)
Sus-mesocolic0.946 (0.796 to 0.986)
Sub-mesocolic0.983 (0.928 to 0.996)
Pelvis0.495 (-0.903 to 0.873)
Viscera0.323 (-1.634 to 0.830)
ADP0.999 (0.994 to 1.000)
PrimaryIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.607 (-0.155 to 0.909)
Sus-mesocolic0.613 (0.038 to 0.887)
Sub-mesocolic-0.043 (-0.739 to 0.600)
Pelvis0.451 (-0.177 to 0.826)
Viscera0.792 (0.392 to 0.943)
ADP0.996 (0.984 to 0.999)
PrimaryIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.755 (-0.368 to 0.952)
Sus-mesocolic0.760 (0.074 to 0.940)
Sub-mesocolic-0.091 (-5.666 to 0.750)
Pelvis0.622 (-0.429 to 0.905)
Viscera0.884 (0.563 to 0.971)
ADP0.998 (0.992 to 1.000)
PrimaryIndividual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After four cycles of chemoterapy, 12 weeks
Reported as:
Geometric mean · proportion of agreement
Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic1.000 (1.000 to 1.000)
Sus-mesocolic1.000
Sub-mesocolic1.000 (0.999 to 1.000)
Pelvis0.971 (0.891 to 0.993)
ADP1.000
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After four cycles of chemoterapy, 12 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Sus-mesocolic1.000
Sub-mesocolic1.000 (0.998 to 1.000)
Pelvis0.944 (0.803 to 0.986)
ADP1.000
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After four cycle of chemoterapy, 12 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Sus-mesocolic0.794 (0.385 to 0.944)
Sub-mesocolic0.794 (0.322 to 0.950)
Pelvis0.975 (0.908 to 0.994)
ADP0.987 (0.950 to 0.997)
PrimaryIntra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Number · proportion of agreement
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Sus-mesocolic0.885 (0.556 to 0.971)
Sub-mesocolic0.885 (0.487 to 0.974)
Pelvis0.987 (0.952 to 0.997)
ADP0.993 (0.974 to 0.998)
PrimaryIntra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.930 (0.703 to 0.986)
Sus-mesocolic0.654 (0.038 to 0.910)
Sub-mesocolic0.767 (0.302 to 0.937)
Pelvis0.088 (-0.467 to 0.639)
Viscera0.686 (0.184 to 0.910)
ADP0.804 (0.320 to 0.957)
PrimaryIntra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Geometric mean · proportion of agreement
Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
proportion of agreementFunctional Imaging
Supra-diaphragmatic0.964 (0.826 to 0.993)
Sus-mesocolic0.791 (0.073 to 0.953)
Sub-mesocolic0.868 (0.463 to 0.967)
Pelvis0.162 (-1.753 to 0.780)
Viscera0.814 (0.311 to 0.953)
ADP0.891 (0.485 to 0.978)
SecondarySpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Number · Spearman's correlation coefficient
Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)
Spearman's correlation coefficientFunctional Imaging
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVmax-0.091 (-0.679 to 0.575)
Spearman correlation test statistics between CA125 and relative variation of PET parameter MTV-0.030 (-0.647 to 0.612)
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN-0.212 (-0.737 to 0.491)
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL-0.212 (-0.737 to 0.491)
Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG-0.164 (-0.715 to 0.526)
SecondarySpearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Number · Spearman's correlation coefficient
Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)
Spearman's correlation coefficientFunctional Imaging
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVmax0.811 (0.082 to 0.967)
Spearman correlation test statistics between CA125 and relative variation of PET parameter MTV0.775 (-0.012 to 0.960)
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN0.811 (0.082 to 0.967)
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL0.811 (0.082 to 0.967)
Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG0.775 (-0.012 to 0.960)
SecondarySpearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

Time frame:
After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)
Reported as:
Number · Spearman's correlation coefficient
Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125
Spearman's correlation coefficientFunctional Imaging
Relative variations between pre-therapeutic and after one cycle of chemotherapy0.103 (-0.567 to 0.685)
Relative variations between pre-therapeutic and after four cycles of chemotherapy-0.571 (-0.919 to 0.361)
SecondaryComplete Surgery Resection
Time frame:
Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery
Reported as:
Count of participants · Participants
Complete Surgery Resection
ParticipantsFunctional Imaging
Yes10
No0
SecondaryDescriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-25.4 ± 33.1
Stable disease-9.6 ± 29.8
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.602 · Mean difference (net): 0.273
SecondaryDescriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. RRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-67.3 ± 29.3
Stable disease-11.3 ± 31.1
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.067 · Mean difference (net): 3.361
SecondaryDescriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-94.7 ± 11.4
Stable disease12.9 ± 52.9
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.036 · Mean difference (net): 4,390
SecondaryDescriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-38.5 ± 47.6
Stable disease-3.3 ± 5.4
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.296 · Mean difference (net): 1.091
SecondaryDescriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-21.8 ± 28.8
Stable disease-15.6 ± 22.1
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.794 · Mean difference (net): 0.068
SecondaryDescriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-65.2 ± 29.4
Stable disease-16.2 ± 30.2
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.067 · Mean difference (net): 3.361
SecondaryDescriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-63.5 ± 52.4
Stable disease-15.2 ± 12.9
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.296 · Mean difference (net): 1,091
SecondaryDescriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-97.7 ± 9.4
Stable disease-7.5 ± 18.2
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.036 · Mean difference (net): 4.390
SecondaryDescriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-24.9 ± 31.9
Stable disease-21.8 ± 11.4
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.794 · Mean difference (net): 0.068
SecondaryDescriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response-66.9 ± 29.0
Stable disease-14.7 ± 33.8
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.036 · Mean difference (net): 4.390
SecondaryDescriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After one cycle of chemotherapy, 3 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response9.3 ± 209.7
Stable disease4.3 ± 25.1
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.602 · Mean difference (net): 0.273
SecondaryDescriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1

In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

Time frame:
After four cycles of chemotherapy, 12 weeks
Reported as:
Median · change in relative variance
Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1
change in relative varianceFunctional Imaging
Partial response38.6 ± 274.5
Stable disease-18.0 ± 40.1
Statistical analysis
  • Functional Imaging · Kruskal-Wallis · p = 0.192 · Mean difference (net): 1.705
SecondaryPeritoneal Extent Assessed by Fagotti Score Using MRI Data

The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscale values corresponds to Fagotti score.

Time frame:
Pre-therapeutic
Reported as:
Count of participants · Participants
Peritoneal Extent Assessed by Fagotti Score Using MRI Data
ParticipantsFunctional Imaging
42
84
102
121
Missing1
SecondaryPeritoneal Extent Assessed by Fagotti Score Using MRI Data

TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscales corresponds to Fagotti score.

Time frame:
Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery
Reported as:
Count of participants · Participants
Peritoneal Extent Assessed by Fagotti Score Using MRI Data
ParticipantsFunctional Imaging
01
21
42
62
83
101
SecondaryOverall Survival
Time frame:
10 months
Reported as:
Number · percentage of patients
Overall Survival
percentage of patientsFunctional Imaging
Overall Survival90 (47.3 to 98.5)
SecondaryProgression-free Survival as Per RECIST v1.1
Time frame:
9, 13, 14 months
Reported as:
Number · percentage of patients
Progression-free Survival as Per RECIST v1.1
percentage of patientsFunctional Imaging
9 months90.0 (47.3 to 98.5)
13 months78.8 (38.1 to 94.3)
14 months67.5 (29.1 to 88.2)

Adverse events

Collected over All adverse events are recorded from the first visit (J0 inclusion) until 4 weeks after the third PET/MRI examination. Beyond this period, only SAE likely to be related to the research or the medical device or to the procedure of implementation of the medical device are reported.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Functional Imaging1/11 (9.1%)3/11 (27.3%)11/11 (100%)
Most frequent serious events
Most frequent serious events
EventFunctional Imaging
AnemiaBlood and lymphatic system disorders1/11
Colonic obstructionGastrointestinal disorders1/11
VomitingGastrointestinal disorders1/11
SepsisInfections and infestations1/11
Most frequent other events
Showing 10 of 30
Most frequent other events
EventFunctional Imaging
AnemiaBlood and lymphatic system disorders3/11
AlopeciaSkin and subcutaneous tissue disorders3/11
AscitesGastrointestinal disorders2/11
ConstipationGastrointestinal disorders2/11
DiarrheaGastrointestinal disorders2/11
NauseaGastrointestinal disorders2/11
FatigueGeneral disorders2/11
FeverGeneral disorders2/11
Allergic reactionImmune system disorders2/11
Bronchial infectionInfections and infestations2/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)Functional Imaging
Median67.0 (41.8 to 77.3)
Sex: Female, Male
Sex: Female, Male(Participants)Functional Imaging
Female11
Male0
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Functional Imaging
Proven epithelial carcinoma of gynaecological origin
Proven epithelial carcinoma of gynaecological origin(Participants)Functional Imaging
Yes11
No0
Location of the tumour
Location of the tumour(Participants)Functional Imaging
Ovaries9
Trunk1
Primitive peritoneal1
Histological type
Histological type(Participants)Functional Imaging
Serous11
Other type0
Stage of the tumour
Stage of the tumour(Participants)Functional Imaging
III-c5
IV6
Total Fagotti Score
Total Fagotti Score(Participants)Functional Imaging
42
84
103
121
Not available1

6 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Institut Bergonié
    Bordeaux, Gironde 33076, France
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02792959
Lead sponsor
Institut Bergonié
Collaborators
Roche Pharma AG, Ligue contre le cancer, France
Responsible party
Sponsor
First posted
Jun 8, 2016
Start date
Aug 2014
Primary completion
Jan 2017
Completion
Aug 2017
Results posted
Apr 21, 2021
Last update
Apr 21, 2021

Study contacts

Anne-Laure CAZEAU, MD
study chair · Institut Bergonié

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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